An interventional study of Active Low-Intensity Focused Ultrasound (LIFU) and Sham Low-Intensity Focused Ultrasound (LIFU) in Gambling Disorder, Gambling Addiction and Gambling Problem, sponsored by University of Virginia. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by University of Virginia · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to learn whether low-intensity focused ultrasound (LIFU) is safe and may help reduce gambling-related symptoms in adults seeking treatment for gambling disorder.
The main questions it aims to answer are:
Researchers will compare participants who receive active LIFU with participants who receive sham LIFU to see whether active treatment leads to greater reductions in gambling behavior.
Participants will:
Low-intensity focused ultrasound is a noninvasive technique that uses focused sound waves to influence brain activity. Researchers believe this approach may affect brain circuits involved in reward, cravings, and decision-making that contribute to gambling disorder.
158 studies on the registry are indexed under Gambling; 42 are open to participants now.
This study's planned enrollment of 54 is below the median of 66 across 128 interventional studies indexed under Gambling.
Browse Gambling studies →University of Virginia is the lead sponsor of 675 studies on the registry; 138 are open to participants now.
Of its 61 completed or terminated interventional studies of FDA-regulated products, 42 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Low Intensity Focused Ultrasound * Each course comprises of three 10-minute sessions of Active LIFU per day (5 minutes to the left NAc, then 5 minutes to the right) on three treatment days scheduled within a 5-day window (i.e., nine sessions per course). * During the randomized phase (through post-LIFU Day 30), the trial operates as a parallel-group comparison of active LIFU versus sham, with both arms receiving standard-of-care, once-weekly telehealth CBT.
Device: Active Low-Intensity Focused Ultrasound (LIFU)
Device: Low Intensity Focused Ultrasound * Each course comprises of three 10-minute sessions of Sham LIFU per day (5 minutes to the left NAc, then 5 minutes to the right) on three treatment days scheduled within a 5-day window (i.e., nine sessions per course). * Sham session is procedurally identical to Active LIFU session with the exception that no energy is delivered during the procedures. * During the randomized phase (through post-LIFU Day 30), the trial operates as a parallel-group comparison of active LIFU versus sham, with both arms receiving standard-of-care once-weekly telehealth CBT. * After the Day 30 primary endpoint and unblinding, the sham arm crosses over to open-label active LIFU and repeats the identical treatment and assessment sequence, so every participant ultimately receives active treatment.
Device: Sham Low-Intensity Focused Ultrasound (LIFU)
Active low-intensity focused ultrasound (LIFU) neuromodulation targeting the left and right nucleus accumbens. Each treatment course comprises three 10-minute sessions per day (5 minutes to the left nucleus accumbens and 5 minutes to the right nucleus accumbens) delivered on three treatment days within a 5-day window, for a total of nine sessions. Participants also receive standard-of-care, once-weekly telehealth cognitive behavioral therapy (CBT).
Sham low-intensity focused ultrasound procedures that are identical to active treatment except that no therapeutic ultrasound energy is delivered. Each treatment course comprises three 10-minute sessions per day on three treatment days within a 5-day window, for a total of nine sessions. Participants also receive standard-of-care, once-weekly telehealth cognitive behavioral therapy (CBT). After completion of the Day 30 primary endpoint assessments and unblinding, participants may cross over to receive open-label active LIFU.
Incidence of Device-Related and Procedure-Related Adverse Events
Number of participants who experience at least one device-related or investigational procedure-related adverse event (AE) or serious adverse event (SAE) during the randomized treatment phase. Adverse event severity and relationship to study procedures will be assessed by the study investigator.
Time frame: Randomization through Day 30
Change From Baseline in Gambling Frequency Measured by the Gambling Timeline Follow-Back (G-TLFB)
The G-TLFB is a calendar-based self-report assessment that uses memory cues and a timeline method to estimate gambling activity over a specified period. Gambling frequency is assessed by retrospectively recording gambling behavior during the assessment period. Higher values indicate greater gambling frequency.
Time frame: Baseline to Day 30
Change From Baseline in Time Spent Gambling Measured by the Gambling Timeline Follow-Back (G-TLFB)
The G-TLFB is a calendar-based self-report assessment that retrospectively records gambling behavior over a specified period. The outcome is the total time spent gambling during the assessment period. Higher values indicate greater time spent gambling.
Time frame: Baseline through Day 90 post-active LIFU treatment
Change From Baseline in Amount of Money Gambled Measured by the Gambling Timeline Follow-Back (G-TLFB)
The G-TLFB is a calendar-based self-report assessment that retrospectively records gambling behavior over a specified period. The outcome is the total amount of money gambled during the assessment period. Higher values indicate greater gambling expenditure.
Time frame: Baseline through Day 90 post-active LIFU treatment
Change From Baseline in Desire to Gamble During a Cue Reactivity Task
Participants will view gambling-related cues and rate their desire to gamble using a visual analog scale ranging from 0 to 100, where 0 indicates no desire to gamble and 100 indicates the strongest desire possible. Higher scores indicate greater desire to gamble.
Time frame: Baseline through Day 90 post-active LIFU treatment
Change From Baseline in Gambling Symptom Severity Measured by the Gambling Symptom Assessment Scale (GSAS)
The Gambling Symptom Assessment Scale GSAS is a 12-item self-report measure of gambling urges, thoughts, and behaviors during the previous week. Total scores range from 0 to 48, with higher scores indicating greater gambling symptom severity.
Time frame: Baseline through Day 90 post-active LIFU treatment
Change From Baseline in Gambling Symptom Severity Measured by the Pathological Gambling Yale-Brown Obsessive Compulsive Scale (PG-YBOCS)
The Pathological Gambling Yale-Brown Obsessive Compulsive Scale (PG-YBOCS) is a clinician-administered measure of gambling-related thoughts, urges, and behaviors. Total scores range from 0 to 40, with higher scores indicating greater gambling symptom severity.
Time frame: Baseline through Day 90 post-active LIFU treatment
Change From Baseline in Depression Symptom Severity Measured by the Patient Health Questionnaire-9 (PHQ-9)
The Patient Health Questionnaire-9 (PHQ-9) is a 9-item self-report measure of depressive symptoms. Total scores range from 0 to 27, with higher scores indicating greater depression symptom severity.
Time frame: Baseline through Day 90 post-active LIFU treatment
Change From Baseline in Anxiety Symptom Severity Measured by the Generalized Anxiety Disorder-7 (GAD-7)
The Generalized Anxiety Disorder-7 (GAD-7) is a 7-item self-report measure of anxiety symptoms. Total scores range from 0 to 21, with higher scores indicating greater anxiety symptom severity.
Time frame: Baseline through Day 90 post-active LIFU treatment
Change From Baseline in Quality of Life Measured by the World Health Organization Quality of Life-BREF (WHOQOL-BREF)
The World Health Organization Quality of Life-BREF (WHOQOL-BREF) is a 26-item self-report measure that assesses physical, psychological, social, and environmental domains of quality of life. Higher scores indicate better quality of life.
Time frame: Baseline through Day 90 post-active LIFU treatment
Start is estimated for Feb 2027; primary completion for Dec 2028, 22 months later.
Of 47 non-industry interventional studies with no phase under Gambling, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 51. This study's planned 22 months is above that.
Counting every sponsor, half of 47 studies reached it within 16 months; a quarter within 10 and three quarters within 51.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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